Home News FDA reverses marketing ban on JUUL vaping products

FDA reverses marketing ban on JUUL vaping products

The U.S. Food and Drug Administration on Thursday announced it has reversed its marketing ban on JUUL Labs, reigniting the potential for federal authorization of the e-cigarette company’s products.

The reversal comes nearly two years after the federal health agency ordered JUUL to stop selling products — including its vaping devices as well as its tobacco and menthol-flavored pods.

In June 2022, the FDA raised concerns over “potentially harmful chemicals” in JUUL’s e-cigarettes and “insufficient and conflicting data” in the company’s applications to sell its products in the United States.

JUUL at the time said it disagreed with the FDA and has long argued its products can help users stop smoking cigarettes.

The ban was paused just a few weeks later, and JUUL products were allowed to remain on store shelves pending the vaping company’s appeal.

Since then, the FDA has “conducted additional substantive review of the applications in a number of disciplines, including toxicology, engineering, social science, and clinical pharmacology,” the agency said in a statement on Thursday.

It has also “gained more experience with various scientific issues regarding e-cigarette products, and there have been new litigation outcomes in cases about [Marketing Denial Orders] for e-cigarette products from other manufacturers,” the FDA added.

The reversal was also in part triggered by a “review of information provided by the applicant.”

The FDA on Thursday also emphasized the recission “is not an authorization or a denial and does not indicate whether the applications are likely to be authorized or denied.” Instead it returns JUUL’s “applications to pending status, under substantive review by the FDA.”

JUUL in a statement to ABC News said they “appreciate the FDA’s decision and now look forward to re-engaging with the agency on a science- and evidence-based process to pursue a marketing authorization for JUUL products.”

It continued: “We remain confident in the quality and substance of our applications and believe that a full review of the science and evidence will demonstrate that our products meet the statutory standard of being appropriate for the protection of public health.”

The vaping company also confirmed its products will remain available during the FDA’s renewed review of its application.


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